What is Annex 2 form?

REQUEST FOR AUTHORISATION OF A SUBSTANTIAL AMENDMENT TO A CLINICAL TRIAL. ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR. THE OPINION OF THE ETHICS COMMITTEES IN THE COMMUNITY.

What is Annex 1 clinical trial?

Annex 1: A[pplication form. REQUEST FOR AUTHORISATION OF A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS COMMITTEES IN THE COMMUNITY.

What is an Annex 1 form?

Annex 1: Clinical trial Application Form. REQUEST FOR AUTHORISATION OF A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR. HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS.

What is Eudralex volume10?

Volume 10 of the publication “The rules governing medicinal products in the European Union” contains guidance documents applying to clinical trials. Additionally, new documents were prepared to cover new aspects introduced by the same Regulation. …

Which is the latest version of EudraCT Annex 1?

Annex 1 revised : PDF version – Word version (revision 4 of November 2009 ; updated on 22 of November 2019). EudraCT Version 8.0 uses the Revision 4 dated November 2009 of the Clinical Trials Application Form (updated on November 22, 2019). For more information please refer to the EudraCT website.

What does EudraCT stand for in clinical trials?

Welcome to the EudraCT public home page. EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the European database for all interventional clinical trials on medicinal products authorized in the European Union (EEA) and outside the EU/EEA if they are part of a Paediatric Investigation Plan (PIP) from 1 May 2004 onwards.

What can I do with an EudraCT Number?

The following tasks can be performed from this page: Before any functionality of EudraCT can be used for a given clinical trial, a EudraCT number must be created in order to provide a unique reference for that trial. Create, save XML/PDF files of clinical trial applications locally.

Are there any clinical trials regulations for EudraLex?

Until the Clinical Trials Regulation becomes applicable sponsors should follow the documents relevant to the Clinical Trials Directive.